MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 CONCERTO NYLON; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION

Model Number	NV-2-6-HELIX
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/02/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
Medtronic received a report that there was a detach defect with a concerto coil.The reported device and any accessory devices were prepared as indicated in the instructions for use (ifu).It was unknown if any patient symptoms or complications were associated with this event.
Event or Problem Description
Additional information received reported a new product was used to complete the procedure.
Additional Manufacturer Narrative
Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Additional Manufacturer Narrative
H3: product analysis as found condition- the concerto device was returned for analysis within a shipping box, within a sealed plastic biohazard pouch, and within an opened concerto outer carton.Visual inspection/damage location details ¿ no introducer sheath was returned.The break indicator was found to be broken, with the release wire entirely retracted from the pusher (actuator interface and release wire were not returned).The pushwire was found bent at ~12.4cm, bent at ~60.8cm and kinked at ~82.2cm from the broken proximal end.The shield coil was found undamaged.The implant coil was already detached and not returned.Dried blood was found within the retainer ring and lumen stop.The retainer ring was found undamaged.Testing/analysis ¿ the lumen stop was found damaged and could not be reliably measured.The coin was not returned for further assessment and the outer diameter could not be measured.Conclusion - based on the customer report and device analysis, the customer report of "non-detachment" could not be confirmed as the concerto device was returned broken with the implant coil already detached.However, this event could not be ruled out.The concerto implant coil was not returned; therefore, any contribution the coil had to the non-detachment was unable to be determined.The pusher was found broken at the proximal end, thus confirming a detachment attempt; however, the type of detachment attempted was undetermined.A possible cause of non-detach could be that the pusher was found to have blood under the ptfe within the lumen stop.It is possible that the blood contributed towards the non-detachment, but this was unable to be confirmed.Other possible causes of failure are but not limited to, damaged pusher, intact twr crimps, and detachment stick bent or out of specification; however, the likely cause was undetermined.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: CONCERTO NYLON
• Common Device Name: DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• Manufacturer (Section G): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• Manufacturer Contact: justin ellis ; 9775 toledo way; irvine, CA 92618 ; 7635265677
• MDR Report Key: 22087994
• Report Number: 9617601-2025-00491
• Device Sequence Number: 20804769
• Product Code: KRD
• UDI-Device Identifier: 00847536044876
• UDI-Public: (01)00847536044876(17)271122(10)230140610
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K090046
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/05/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: NV-2-6-HELIX
• Device Catalogue Number: NV-2-6-HELIX
• Device Lot Number: 230140610
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/21/2025
• Supplement Date Received by Manufacturer: 05/27/2025; 07/11/2025
• Initial Report FDA Received Date: 05/27/2025
• Supplement Report FDA Received Date: 06/12/2025; 08/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/22/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown